Conventional sterilization methods for injectable solutions or suspensions generally comprise the exposure of the preformed mixture to high temperatures or ionizing radiation sufficient to kill any microorganisms present. This approach cannot be used with materials that will be adversely affected by the sterilizing conditions. Another approach is the sterile membrane filtratration system in which the solution is passed through a sterile Millipore filter system. This technique can be cumbersome, involved and expensive. Both approaches, however, fail to come to grips with the problem associated with solutions which tend to decompose relatively rapidly thereby having an intolerably low shelf life. Such materials as sodium ascorbate, for example, are available in 50 ml vials containing 25% sodium ascorbate solution (12.5 grams sodium ascorbate) preserved with sodium sulfite and benzyl alcohol. When such materials are used, for example, in the treatment of humans and animals in the manner described by F. R. Klenner (J. International Acad. Prev. Med., vol. 1, No. 1, pages 49-65 (1974) and W. O. Belfield et al (J. International Acad. Prev. Med., vol. 2, No. 3, pages 10- 26 (1975), and E. Cameron et al, J. Internat. Res. Commun., vol. 1, No. 6, pages 38 (1973), the sulfite produced adverse side effects resembling those of beri-beri as a result of the reaction of the sulfite with the patient's vitamin B.sub.1. The manufacturer, upon request, has produced vials without the sulfite but the manufacturer believes the shelf life is so short that they do not distribute the product through normal channels. What is needed is an inexpensive means for sterilizing sensitive materials in the solid state so that they can be stored for long periods and mixed with sterile water immediately prior to use. This invention describes such an approach.
It is accordingly an object of this invention to provide a simple economical method for sterilizing sensitive solid materials.
It is another object of this invention to provide a sterile container of a sensitive solid material.
A further object of this invention is to provide sterilization with a non-toxic, volatile sterilizing agent that does not have to be removed from the mixture before use, and in the quantities employed for sterilization it would be normally metabolized by the body without any unfavorable side effects on injection.
These and other objects of this invention will be readily apparent from the following description.